BEUDAMED
    FDA Enforcement Class II Ongoing

    HoverMatt, 39" W x 78" L, REF: HM39SPU-B

    Recall: Z-2394-2023 · Reported August 16, 2023

    Enforcement

    Recall Number
    Z-2394-2023
    Event ID
    92655
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Sustainability Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 16, 2023
    Initiation Date
    June 21, 2023
    Classification Date
    August 10, 2023
    Address
    1810 W Drake Dr, N/A, Tempe, AZ, 85283-4327, United States

    Description

    HoverMatt, 39" W x 78" L, REF: HM39SPU-B

    Reason

    39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there may be a decreased surface area available to distribute the patient's weight across, which may increase the effort exerted by staff for a lateral patient transfer, and there may be increased friction and shearing forces when the patient is moved resulting in skin tear injury.

    Code Info

    UDI-DI: 07613327487718, Lot: 0000185127, Distribution Dates: 11/28/2022-12/08/2022

    Distribution

    US: WI, ID, CA, FL, HI, MD, RI, AZ, MA, GA, IL

    Quantity

    340